OncoMatch/Clinical Trials/NCT03128034
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia
Is NCT03128034 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Cyclosporine and Fludarabine Phosphate for acute lymphoblastic leukemia.
Treatment: Cyclosporine · Fludarabine Phosphate · Mycophenolate Mofetil — This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: PTPRC CD45 expression (CD45-expressing leukemic blasts required if not in remission)
Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: myeloablative allogeneic hematopoietic cell transplant
Lab requirements
Blood counts
circulating blast count < 10,000/mm^3 (control with hydroxyurea or similar agent is allowed)
Kidney function
estimated creatinine clearance > 50 ml/min (Cockcroft-Gault)
Liver function
bilirubin within normal limits, AST and ALT < 2x ULN (except Gilbert's disease: bilirubin up to 3x ULN)
Cardiac function
No symptomatic coronary artery disease; no cardiac medications for anti-arrhythmic or inotropic effects; left ventricular ejection fraction >= 35%
Patients should have a circulating blast count of less than 10,000/mm^3 (control with hydroxyurea or similar agent is allowed); estimated creatinine clearance greater than 50/ml per minute (Cockcroft-Gault); normal hepatic function (bilirubin within normal limits, AST and ALT < 2x ULN, except Gilbert's disease: bilirubin up to 3x ULN); no symptomatic coronary artery disease; left ventricular ejection fraction < 35% [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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